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LY3832479

Phase 3

COVID-19 | Monoclonal antibody | Other |Eli Lilly and Company|Trials Updated: Dec 6, 2021

LY3832479 development status

Highest phase Phase 3 (NCT04497987)
Phase scored for LLYPhase 1
Registered trials 5 across 1 sponsor since Jun 2020

LY3832479 target and mechanism

ModalityMonoclonal antibody

Also known as LY-CoV016, Etesevimab

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment44

FDA Designations

No designations recorded

LY3832479 clinical trials

LY3832479 · 2 trials · 1 indication

Phase 1 2
NCT04611789A Study of LY3832479 (LY-CoV016) in Healthy Participants 1Healthy
COMPLETED18 Analytics
NCT04441931A Study of LY3832479 (LY-CoV016) in Healthy ParticipantsHealthy
COMPLETED26 Analytics
PHASE1COMPLETED
A Study of LY3832479 (LY-CoV016) in Healthy Participants 1
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study of LY3832479 (LY-CoV016) in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Tlast (AUC[0-tlast]) of LY3832479
Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time 0 to tlast (AUC\[0-tlast\]) of LY3832479.

PK: Maximum Serum Concentration (Cmax) of LY3832479
Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose

PK: Maximum Serum Concentration (Cmax) of LY3832479.

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Baseline through Follow-up (Week 12)

The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Secondary Endpoints

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479
Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85
PK: Maximum Serum Concentration (Cmax) of LY3832479
Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3832479EXPERIMENTALParticipants received single subcutaneous dose of 350 milligrams (mg) and 1000 mg LY3832479.
PlaceboPLACEBO_COMPARATORParticipants received single subcutaneous dose of Placebo.

Interventions

NameTypeDescription
LY3832479DRUGAdministered subcutaneously
PlaceboDRUGAdministered subcutaneously
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy as determined by medical evaluation including medical history and physical examination * Are willing to follow study procedures, including having nasal or nasopharyngeal swabs collected * Have a body mass index (BMI) within the range of greater than or equa...

Countries:United States
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Frequently asked questions about LY3832479

What is LY3832479?

LY3832479 is an investigational small molecule developed by Eli Lilly and Company for COVID-19. It has been studied in Phase 1 clinical trials involving healthy participants. The drug is not approved and remains in clinical development.

What is LY3832479 used for?

LY3832479 is being developed for the treatment of COVID-19. Its clinical program has focused on Phase 1 studies in healthy volunteers, and it has not yet been evaluated in later-stage trials for efficacy in patients with the disease.

Who makes LY3832479?

LY3832479 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical trials evaluating the drug.

What phase is LY3832479 in?

LY3832479 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The drug has not been approved by the FDA and remains investigational.

What clinical trials is LY3832479 in?

LY3832479 has been studied in two completed Phase 1 trials: NCT04611789, which enrolled 18 healthy participants, and NCT04441931, which enrolled 26 healthy participants. Both were conducted in the United States and are now completed.

Is LY3832479 the same as LY-CoV016?

Yes, LY3832479 is also known as LY-CoV016. The two names refer to the same investigational drug developed by Eli Lilly and Company for COVID-19, and both appear in the titles of its Phase 1 clinical trials.